Press Release Details

CONCORD, Calif.--(BUSINESS WIRE)--
Cerus Corporation (NASDAQ:CERS) announced today that its European Phase
3 clinical trial of red blood cells treated with the INTERCEPT Blood
System for acute anemia in cardiovascular surgery patients met the
primary endpoint. Preliminary analysis demonstrated that the mean
hemoglobin content (53.1g) of INTERCEPT-treated red blood cell
components (RBCs) on day 35 of storage met the protocol-defined criteria
for equivalence based on the inferiority margin of 5g compared to
conventional red blood cell components (55.8g). The investigators plan
to submit data from the study for presentation at upcoming scientific
congresses.

"In our prior US Phase 3 study in a similar patient population,
INTERCEPT red cells were shown to be non-inferior to control red cells
in 148 patients based on a composite endpoint of myocardial infarction,
renal failure and death," said Dr. Laurence Corash, Cerus' chief medical
officer. "The data from the recent Phase 3 study met the European
criteria for red blood cell components for transfusion and demonstrated
sufficient hemoglobin content and in vitro quality compared to untreated
red cells. We believe that the successful results from this study,
combined with data from the prior Phase 3 study, support the safety and
efficacy of the INTERCEPT RBC system for CE Mark registration."

The randomized, double-blind, controlled, multi-center Phase 3 clinical
trial of the INTERCEPT red blood cell system evaluated the efficacy of
the INTERCEPT System to process RBCs with quality and mean hemoglobin
content (>40 g) suitable to support transfusion according to the
European Directorate for the Quality of Medicines (EDQM). The blood
components were transfused to 51 cardiovascular surgery patients at two
German clinical trial sites to evaluate transfusion efficacy and overall
safety. Patients undergoing procedures for either coronary artery bypass
grafting (CABG), valve repair or combined procedures received study
transfusions during a 7-day treatment period that included the day of
surgery and 6 days post-operatively. The patients received either
INTERCEPT-treated RBCs or control RBCs not treated for pathogen
inactivation.

Red blood cell components for both clinical sites were manufactured at
the German Red Cross blood center in Frankfurt, and the study RBCs were
stored for up to 35 days prior to transfusion. The primary endpoint of
equivalence of mean hemoglobin content between INTERCEPT RBCs and
conventional RBCs was met within the protocol specified 5g equivalence
margin based on over 750 study RBC components manufactured. The
secondary efficacy endpoints also demonstrated suitability for
transfusion based on mean hematocrit of 60.4% (acceptance range: 55-70%)
and mean end of storage hemolysis of 0.28% (acceptance range < 0.8%).
There were no statistical differences in the adverse event rates between
recipients of INTERCEPT treated and control RBCs. There were no
clinically relevant trends in severe or serious treatment related
adverse events by system organ class. The observed adverse events were
within the expected spectrum of co-morbidity and mortality for patients
of similar age and with advanced cardiovascular diseases undergoing
cardiovascular surgery requiring red cell transfusion. No patients
exhibited an immune response to INTERCEPT treated RBCs.

The INTERCEPT red cell system is being developed to improve blood
transfusion safety due to risks of transfusion transmitted infections
(TTIs) and may have the additional benefits of enhanced safety with
respect to transfusion-associated graft versus host disease (TA-GVHD),
with the possibility of enhanced RBC viability compared to gamma
irradiated RBC components. S-303 treated RBCs contain much less plasma
than conventional RBC components, and thus offer the potential for
reduced plasma-mediated allergic reactions and transfusion-related acute
lung injury (TRALI). Cerus recently reported the results from a US Phase
2 clinical study of the INTERCEPT red cell system in healthy blood
donors, and plans to include these data in the filing for CE Mark
approval anticipated in the second half of 2016.

ABOUT CERUS

Cerus Corporation is a biomedical products company focused in the field
of blood safety. Cerus currently markets and sells the INTERCEPT Blood
System for both platelets and plasma in Europe, the Commonwealth of
Independent States, the Middle East and selected countries in other
regions around the world. In the United States, the INTERCEPT platelet
and plasma systems have received FDA approval. The INTERCEPT red blood
cell system is in clinical development. See http://www.cerus.com
for information about Cerus.

INTERCEPT and the INTERCEPT Blood System are trademarks of Cerus
Corporation.

This press release contains forward-looking statements. Any
statements contained in this press release that are not statements of
historical fact may be deemed to be forward-looking statements,
including, without limitation, statements relating toCerus’ plan
to file for CE Mark approval of the INTERCEPT Blood System for red blood
cells and the anticipated timing thereof, Cerus’ belief that the results
from the Phase 3 clinical trial supports CE Mark registration, Cerus’
development of the INTERCEPT Blood System for red blood cells and its
therapeutic potential, as well as plans to present data regarding study
results. These forward-looking statements are based upon Cerus’ current
expectations. Actual results could differ materially from these
forward-looking statements as a result of certain factors, including,
without limitation, risks associated with the uncertainty of future
clinical trial results,the uncertain and time-consuming
regulatory process, including the risk that Cerus may never obtain
regulatory approval of the INTERCEPT Blood System for red blood cells in
any jurisdiction; Cerus’ need for additional capital to support its
clinical development programs; and other risks detailed in Cerus'
filings with the Securities and Exchange Commission (SEC), including in
Cerus' quarterly report on Form 10-Q for the quarter ended September 30,
2014, filed with the SEC on November 7, 2014. You are cautioned not to
place undue reliance on these forward-looking statements, which speak
only as of the date of this press release. Cerus does not undertake any
obligation to update any forward-looking statements as a result of new
information, future events, changed assumptions or otherwise.